The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Dressing Chang & Wound Management.
Device ID | K920480 |
510k Number | K920480 |
Device Name: | DRESSING CHANG & WOUND MANAGEMENT |
Classification | Wrap, Sterilization |
Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
Contact | Varun Soni |
Correspondent | Varun Soni CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-29 |
Decision Date | 1992-10-19 |